{"id":24901,"date":"2023-12-03T04:57:00","date_gmt":"2023-12-02T20:57:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=24901"},"modified":"2023-12-03T06:18:36","modified_gmt":"2023-12-02T22:18:36","slug":"jama%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e9%80%9a%e5%bf%83%e7%bb%9c%e4%b8%8e%e6%80%a5%e6%80%a7%e5%bf%83%e6%a2%97%e6%82%a3%e8%80%85%e7%9a%84%e4%b8%b4%e5%ba%8a%e9%a2%84%e5%90%8e","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=24901","title":{"rendered":"[JAMA\u53d1\u8868\u8bba\u6587]\uff1a\u901a\u5fc3\u7edc\u4e0e\u6025\u6027\u5fc3\u6897\u60a3\u8005\u7684\u4e34\u5e8a\u9884\u540e"},"content":{"rendered":"\n

Original Investigation <\/p>\n\n\n\n

October 24\/31, 2023<\/p>\n\n\n\n

Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial<\/h1>\n\n\n\n

Yuejin\u00a0Yang,\u00a0Xiangdong\u00a0Li,\u00a0Guihao\u00a0Chen,\u00a0et al<\/h3>\n\n\n\n

JAMA.\u00a0<\/em>2023;330(16):1534-1545. doi:10.1001\/jama.2023.19524<\/h3>\n\n\n\n

<\/a>Key Points<\/p>\n\n\n\n

Question<\/strong>  Among patients with acute ST-segment elevation myocardial infarction (STEMI), does the addition of a traditional Chinese medicine compound (Tongxinluo) as an adjunctive treatment to guideline-directed therapies improve clinical outcomes?<\/p>\n\n\n\n

Findings<\/strong>  In this randomized, double-blind, placebo-controlled clinical trial of 3777 patients with STEMI, oral administration of Tongxinluo for 12 months, compared with placebo, significantly reduced the primary end point of 30-day major adverse cardiac and cerebrovascular events (rate of MACCEs, 3.4% vs 5.2%), with a significant reduction in cardiac death (3.0% vs 4.2%). These benefits persisted within 1 year (MACCEs: 5.3% vs 8.3%; cardiac death: 4.5% vs 6.1%), with no significant difference in major bleeding.<\/p>\n\n\n\n

Meaning<\/strong>  Among patients with STEMI, Tongxinluo improved both 30-day and 1-year clinical outcomes.<\/a><\/p>\n\n\n\n

Abstract<\/p>\n\n\n\n

Importance<\/strong>  Tongxinluo, a traditional Chinese medicine compound, has shown promise in in vitro, animal, and small human studies for myocardial infarction, but has not been rigorously evaluated in large randomized clinical trials.<\/p>\n\n\n\n

Objective<\/strong>  To investigate whether Tongxinluo could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI).<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong>  Randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.<\/p>\n\n\n\n

Interventions<\/strong>  Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months (a loading dose of 2.08 g after randomization, followed by the maintenance dose of 1.04 g, 3 times a day), in addition to STEMI guideline-directed treatments.<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong>  The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year.<\/p>\n\n\n\n

Results<\/strong>\u00a0\u00a0Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group (relative risk [RR], 0.64 [95% CI, 0.47 to 0.88]; risk difference [RD], \u22121.8% [95% CI, \u22123.2% to \u22120.6%]). Individual components of 30-day MACCEs, including cardiac death (56 [3.0%] vs 80 [4.2%]; RR, 0.70 [95% CI, 0.50 to 0.99]; RD, \u22121.2% [95% CI, \u22122.5% to \u22120.1%]), were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs (100 [5.3%] vs 157 [8.3%]; HR, 0.64 [95% CI, 0.49 to 0.82]; RD, \u22123.0% [95% CI, \u22124.6% to \u22121.4%]) and cardiac death (85 [4.5%] vs 116 [6.1%]; HR, 0.73 [95% CI, 0.55 to 0.97]; RD, \u22121.6% [95% CI, \u22123.1% to \u22120.2%]). There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis (<24 hours; 1-30 days; 1-12 months). More adverse drug reactions occurred in the Tongxinluo group than the placebo group (40 [2.1%] vs 21 [1.1%];\u00a0P<\/em>\u2009=\u2009.02), mainly driven by gastrointestinal symptoms.<\/p>\n\n\n\n

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Conclusions and Relevance<\/strong>  In patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI.<\/p>\n\n\n\n

Trial Registration<\/strong>\u00a0\u00a0ClinicalTrials.gov Identifier:\u00a0NCT03792035<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation  October 24\/31, 2 […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24901"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=24901"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24901\/revisions"}],"predecessor-version":[{"id":24902,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/24901\/revisions\/24902"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=24901"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=24901"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=24901"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}